Supporting medical device companies throughout the product lifecycle
The medical device market is rapidly changing. New technologies are leading to ever tighter integration of drugs, devices and biologics, as well as software, electronics and physical products. New regulations are driving the industry towards new approaches for safety, device identification and clinical investigations, to name just a few areas. Increasing pressure on regulators is being passed on to manufacturers and importers. Recent FDA regulations around Combination Products and Unique Device Identification (UDI) and the upcoming finalization of the European Medical Device Regulations require companies to pro-actively manage their device and combination product portfolios to ensure operational efficiency and regulatory compliance.
At Navitas, we have a track record of successful medical device project delivery across many areas, including regulatory affairs, quality management, risk management, device vigilance and track & trace technologies. We offer deep industry insight, paired with project management experience, and work along the three dimensions of processes, people and technology. Our main offerings include, but are not limited to,
- Facilitating Combination Products governance and regulatory strategy.
- Implementing Unique Device Identification (UDI) processes and technologies,
- Improving Complaint Handling and device vigilance,
The Way We Work
We serve clients from the life science industry across multiple regions. We deliver services, technologies, and consultancy engagements to the medical device, biotech, and pharmaceutical sectors. We pride ourselves on our industry leading Networks, setting us apart from our competitors. We are happy to work in large or small teams, depending on the assignment and client requirements. We focus on customer needs and measure both progress and success. Our staff are expert navigators, fulfilling the role of project manager as well as being subject matter experts, delivering value from day one.